Childrens Pain Relief Dye-Free

Product NDC: 67091-119
11-digit product format: 670910119
Labeler code: 67091
Product ID: 67091-119_407e049c-266e-4ecf-9a59-f4f77aace291
Type: HUMAN OTC DRUG
Nonproprietary name: Acteaminophen
Dosage form: SUSPENSION
Route: ORAL
Labeler: WinCo Foods, LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-12-12
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Childrens Pain Relief Dye-Free
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307668	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5ee134b3-b8e9-4621-b0a1-a84d9867ccba	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67091-119-18	Childrens Pain Relief Dye-Free	1 in 1 CARTON	SUSPENSION	1		6
67091-119-18	Childrens Pain Relief Dye-Free	118 mL in 1 BOTTLE	SUSPENSION	118		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 50-100 MPA.S AT 1%)	INACTIVE INGREDIENT	6QM647NAYU	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67091-119	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20240413_5ee134b3-b8e9-4621-b0a1-a84d9867ccba.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 66 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topcare infants pain and fever	ACETAMINOPHEN	Topco Associates LLC	a1145ac3-3e55-4bd5-a53e-6cf869add9a1	2024-07-02	Warnings	Exact identifier application number: M013
Drug Mart Effervescent Pain Relief	ASPIRIN	Discount Drug Mart Inc	1c35f394-a221-6531-e063-6394a90acb8a	2024-07-01	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Wildman Business Group	cdbfcf14-8685-40a9-9778-a3b4329dc1ad	2024-07-01	Warnings	Exact identifier application number: M013
Back Pain Relief Extra Strength Doans	MAGNESIUM SALICYLATE	Wildman Business Group	2e17664f-a83f-48d1-8b2b-37f41eea65b6	2024-07-01	Warnings	Exact identifier application number: M013
Meijer Effervescent Pain Relief	ASPIRIN	Meijer Distribution Inc	17553911-e0fc-e355-e063-6394a90af7b8	2024-06-28	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	4fb4f4b2-c238-4933-b874-08def3b34a28	2024-06-26	Warnings	Exact identifier application number: M013
good neighbor pharmacy pain and fever childrens	ACETAMINOPHEN	Amerisource Bergen	ca0833ef-837b-47dc-8676-e016af96622c	2024-06-26	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	4a030c3e-8104-4a0a-98c5-6ab469451f20	2024-06-26	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Padagis Israel Pharmaceuticals Ltd	a426dd82-b2d6-405e-b0af-cfb1310a6e19	2024-06-26	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	WALMART INC. (see also Equate)	7d86a03f-74f4-4b24-b6a6-8747acfe905e	2024-06-26	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	5bcc5da9-7e64-4308-a5be-2f47a8ca774d	2024-06-25	Warnings	Exact identifier application number: M013
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	NuCare Pharmaceuticals,Inc.	9e691264-d48a-6b48-e053-2995a90a9352	2024-06-20	Warnings	Exact identifier application number: M013
Aspirin	REGULAR STRENGTH ENTERIC COATED ASPIRIN	NuCare Pharmceuticals,Inc.	a0705f4f-55cb-214a-e053-2995a90aa680	2024-06-20	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN 500 MG	Lil' Drug Store Products, Inc.	ee8e0e79-4da4-101f-e053-2a95a90a30a4	2024-06-19	Warnings	Exact identifier application number: M013
Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Lil' Drug Store Products, Inc.	b3a06e4b-0b31-4e2a-8dd1-9de85760477b	2024-06-19	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Meijer Distribution Inc	43c3fe72-a4ef-48a6-bc22-a644919c0c5c	2024-06-17	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	093182a6-3ed8-5a3f-e063-6294a90a354a	2024-06-14	Warnings	Exact identifier application number: M013
ACETAMINOPHEN PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	093199be-e92a-6f60-e063-6294a90a8533	2024-06-14	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES , LLC.	09315a3d-bb2d-4f06-e063-6294a90a3bd3	2024-06-14	Warnings	Exact identifier application number: M013
Pain Relief Regular Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	613bc633-0426-41a7-aea9-9ff56311b607	2024-06-13	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	6
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	6
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	6
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	6
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	6
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	6
307668	APAP 32 MG/ML Oral Suspension	SY	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67091-119-18	67091011918	1 BOTTLE in 1 CARTON (67091-119-18) / 118 mL in 1 BOTTLE	1 bottle	2014-12-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Childrens Pain Relief Oral Suspension Dye-Free Grape	WinCo Foods, LLC	2024-04-11	HUMAN OTC DRUG LABEL	6